Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Dietary Supplement: Lutein; Dietary Supplement: Placebo

• Registration Number: NCT04843813
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

Detailed Description

A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.

Study Timeline

• Study Start: 2021-03-26
• Status Verified: 2021-04
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-09
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-15
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-64.9 years
• Self-reported relapsing-remitting MS (RRMS) diagnosis
• Expanded Disability Status Scale (EDSS) score between 0-3.5
• Macular Pigment Optical Density at baseline (MPOD ≤0.35)
• Score ≤55 during the Symbol Digit Modalities Test (SDMT)
• 20/20 or corrected vision
• No presence of color blindness
• No history of age-related macular degeneration
• No history of epileptic seizures

Exclusion Criteria

• Under 18 years or over 64.9 years
• MS diagnosis other than RRMS
• Pregnancy
• Uncorrected vision
• Presence of color blindness
• PDDS score of 7 or more
• Prior diagnosis of age-related macular degeneration
• History of epileptic seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lutein	Lutein	-
Safflower Oil	Placebo	-

Primary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density	4 months (baseline vs. follow-up)	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer
Attentional Accuracy	4 months (baseline vs. follow-up)	Changes in accuracy (%) between groups using a computerized flanker task
Attentional Reaction Time	4 months (baseline vs. follow-up)	Changes in reaction time (ms) between groups using a computerized flanker task
Attentional Resource Allocation	4 months (baseline vs. follow-up)	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task
Attentional Processing Speed	4 months (baseline vs. follow-up)	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States